Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial

BackgroundMastocytosis is frequently associated with mast cell-mediated symptoms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed. MethodsThis randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL). ResultsThe mean ItchyQoL total score and VAS symptom score were significantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms. ConclusionsIn this first comprehensive trial of a sgAH in mastocytosis, rupatadine 20mg daily for 4weeks significantly controlled symptoms and improved patients' quality of life.